Non-Alcoholic Steatohepatitis Patient Characterization and Real-World Management Approaches in Italy

Elisabetta Bugianesi,1 Luca Miele,2,3 Giovanna Donnarumma,4 Katrine Grau,5 Mariarosaria Mancuso,4 Preethy Prasad,5 Andrea Leith,6 Victoria Higgins6 1Division of Gastroenterology, Department of Medical Sciences, University of Torino, AOU Città della Salute e della Scienza, Torino, Italy; 2Dipartimento di Scienze Mediche e Chirurgiche Addominali ed Endocrino Metaboliche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; 3Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy; 4Novo Nordisk SpA, Rome, Italy; 5Novo Nordisk A/S, Søborg, Denmark; 6Adelphi Real World, Bollington, Cheshire, UKCorrespondence: Elisabetta Bugianesi, Email [email protected]: Although the estimated prevalence of non-alcoholic steatohepatitis (NASH) in Italy is 4– 6%, little is known about patient characteristics and care pathways.Aim: To describe patient characteristics and management approaches for patients with NASH or suspected NASH in Italy.Methods: Data were drawn from the Adelphi Real World NASH Disease Specific Programme™, a cross-sectional survey of endocrinologists and gastroenterologists in Italy from January to March 2018. Physicians completed questionnaires for their next five consecutively consulting patients with NASH or suspected NASH. Analyses were descriptive.Results: Seventy-six physicians provided data on 380 patients. The mean age was 58.5 ± 11.1 years and the mean body mass index was 31.8 ± 5.5 kg/m2. A total of 231 patients (61%) had no/non-advanced fibrosis as evaluated by liver biopsy or non-invasive tests. Common diagnostic assessments were cholesterol, hemoglobin A1c, absence of viral hepatitis, and alcohol assessment. At diagnosis, 87% (n=322/372) and 45% (n=169/372) of patients received an ultrasound and liver biopsy, respectively. Overall, 88% of patients were referred from primary to secondary care. Obesity (81%) and type 2 diabetes (62%) were the most commonly recorded comorbidities, with 70% of patients having ≥ 3 comorbidities. Vitamin E (13%) and GLP-1 receptor agonists (13%) were the most prescribed guideline-recommended treatments for all patients.Conclusion: Patients with NASH in Italy had high levels of obesity and comorbidities, while diagnosis and treatment frequently were not according to guidelines. Our data show an unmet need for more targeted diagnosis and treatment in Italian patients with NASH, in order to optimize outcomes.Plain language summary: Fat buildup in the liver, known as fatty liver disease, affects around 4-6% of people in Italy, and can lead to complications if left untreated. However, little is known about how doctors manage people with this disease. Fatty liver disease can only be diagnosed by a liver biopsy, but we found this is only performed in 45% of people, making accurate diagnosis difficult. We also found that 28% of people receive a recommended medication. Overall, increasing doctor awareness of fatty liver medical guidelines may help improve the diagnosis and treatment for people living with fatty liver disease in Italy.Keywords: NASH diagnosis, NASH treatment, NASH resource utilization